MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HELEX SEPTAL OCCLUDER; OCCLUDER, TRANSCATHETER SEPTAL

Device Problem Difficult To Position (1467)

Patient Problem Respiratory Distress (2045)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

A lot number is not available, and the device remains implanted; therefore, an investigation is unable to be performed and a cause of the reported event is unable to be determined.

Event Description

It was reported a gore helex septal occluder was implanted 5-6yrs ago to close a patent foramen ovale due to a history of strokes.In early 2017, the patient presented with shortness of breath and a full cardiac work-up was ordered.A transesophageal echocardiogram/bubble study showed a communication between the atria.On (b)(6) 2017, the physician explored the atria with a glide catheter and noted a 1mm shunt.The physician then attempted to advance a gore cardioform septal occluder to close the shunt; however, he was unable to cross the defect with the delivery catheter.The device was removed and the physician noted device closure was not an option and the patient would be treated medically with aspirin.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6389568
• MDR Text Key: 69482613
• Report Number: 2017233-2017-00116
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 95